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Glenmark receives final approval for generic version of Strattera Capsules

31 May 2017 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg, the generic version of Strattera Capsules, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg, of Eli Lilly and Company.

According to IMS Health sales data for the 12 month period ending April 2017, the Strattera Capsules, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg market achieved annual sales of approximately $1.1 billion.

Glenmark’s current portfolio consists of 117 products authorized for distribution in the US marketplace and approximately 67 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.


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